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Regard™ BTNBLT-REG

by Resource Optimization & Innovation, L.L.C.

Regard™ BTNBLT-REG is a Class I device made by Resource Optimization & Innovation, L.L.C., listed in FDA GUDID since 10 Aug 2023 (UDI-DI 10326053118514), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10326053118514 UDI-DI Date10 Aug 2023ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
Regard™
Generic name
Electrode/transducer strap, reusable
Model / Ref / Catalog
BTNBLT-REG
Primary DI / UDI-DI
10326053118514
FDA product code
ISR
GMDN term
Electrode/transducer strap, reusable
Device class
Class I
Regulation number
890.3025
GUDID distribution status
In Commercial Distribution

Related devices

Category: Electrode/transducer strap, reusable

Similar devices

Other devices filed under FDA product code ISR (Band Or Belt, Pelvic Support).

Other devices from Resource Optimization & Innovation, L.L.C.

See all devices from Resource Optimization & Innovation, L.L.C. →

Properties

  • Single use
  • Over-the-counter
  • Premarket exempt
  • Lot / batch number
Other properties (11, all answered No)